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Monday, May 30, 2011

India Brings the World a Better Vasectomy

(Anatomy of a Testicle - The Vas Deferens is where the RISUG injection is made)

The Better Vasectomy currently goes by the ungainly acronym RISUG (for reversible inhibition of sperm under guidance) and it is the elegantly simple and effective brainchild of "a maverick Indian scientist named Sujoy Guha, who has spent more than 30 years refining the idea while battling bureaucrats in his own country and skeptics worldwide. He has prevailed because, in study after study, RISUG has been proven to work 100 percent of the time. Among the hundreds of men who have been successfully injected with the compound so far in clinical trials, there has not been a single failure or serious adverse reaction. The procedure is now in late Phase III clinical trials in India, which means approval in that country could come in as little as two years."What is RISUG? Where the current vasectomy involves cutting the vas deferens (the tiny tubes that carry sperm made in the testicles to the penis, where they are mixed with nutritive prostate fluids to form semen), Guha's RISUG technique pulls out a section of the vas deferens and injects a nontoxic polymer, which coats the interior of the tube and, amazingly, chemically incapacitate the sperm that flow past, making them incapable of fertilizing an egg.

How do I get a RISUG vasectomy? In India, where RISUG was invented, it's on a fast track to wide availablility. There's no reason you can't go to India and get one just like you can go to any other country and have a medical procedure.

Because RISUG was invented out of the mainstream worldwide pharma/medical device development system, there are obstacles to RISUG's availability in the rest of the world due to a combination of skepticism and, frankly, the inability of the big, important world to deal with something that came out of, to their way of looking at it, nowhere. Wired Magazine explains:

As a contraceptive, RISUG faces a far more difficult road to approval and commercial acceptance than, say, a new antidepressant medication. While an antidepressant would be considered a success if it worked in 75 percent of patients, a contraceptive like RISUG will be compared to a conventional vasectomy, which works more than 99 percent of the time. Furthermore, it has to be free from the serious side effects that were common with early experimental hormone-based male contraceptives. And it cannot cause birth defects down the line—ever. “Nobody wants another thalidomide,” says Ron Weiss, the Canadian vasectomy doctor.

In human tests, RISUG performed extremely well. In the first clinical trial of 17 men, published in 1993, all the subjects who received above a certain dosage became azoospermic—that is, they produced no viable sperm. By 2000, it was in Phase III clinical trials in India, the final stage before approval. The compound was injected into 139 men, and the early results looked promising. In May 2002, it was announced that RISUG was on track for approval in India and would be rolled out on a limited basis within six months.

At around the same time, a World Health Organization team came to visit Guha’s lab in Delhi and examine his data. This itself was a triumph: It meant RISUG was finally on the international radar. Weiss, a long-time advocate of the process, was with the group and performed the operation. But the five-person team came away skeptical.
In its report, the WHO team agreed that the concept of RISUG was intriguing. But they found fault with the homegrown production methods: Guha and his staff made the concoction themselves in his lab, and the WHO delegation found his facilities wanting by modern pharmaceutical manufacturing standards. Furthermore, they found that Guha’s studies did not meet “international regulatory requirements” for new drug approval—certain data was missing. The final recommendation: WHO should pass on RISUG."

Fortunately, that's not the end of the story. A woman activist in the US, fed up with the lack of options for birth control from the male side, has taken up RISUG's cause and in 2010 the Gates Foundation awarded Guha $100,000 - and some much needed recognition - to bring cheap, nontoxic, one-time, 100% effective male birth control to a very needy world.